Many hair care products and hair styling techniques require pulling on the hair and therefore exert force on the hair follicle. Often this results in hair loss. It is an object of the present invention to reduce hair loss and mitigate the damage to hair caused from procedures that pull at the hair by applying a composition of synephrine topically at hair follicles in the scalp or skin.
Many cosmetic procedures used in hair salons and at home involve exerting strong force on the hair to pull it in a direction away from the scalp. For example, washing, brushing and combing hair involves exertion of a force on the hair that pulls the hair away and out of the hair follicle. Brushing hair with vigorous, powerful strokes damages it. Such procedures result in hair shedding or hair loss. It is desirable to minimize hair breakage during hair care and styling procedures. The hair then may be treated and styled as desired while retaining more hair, thereby making the hair appear stronger and more vibrant. It is desirable to be able to continue these hair procedures yet reduce or stop the hair shedding that occurs during the procedure.
Hair styles that are known to result in hair loss due to pulling at the hair include hair extensions and weaves, which can be worn either to conceal hair loss, or purely for cosmetic purposes. Hair weaves create a braid around the head below the existing hairline, to which an extended-wear hairpiece, or wig, is attached. Because the hair of the braid is still growing, it requires frequent maintenance, which involves the hairpiece being removed, the natural hair braided again, and the piece snugly reattached. The tight braiding and snug hairpiece cause tension on the hair that is already at risk for falling out. Shampooing and styling is also known to result in hair loss.
One example of a disorder due to hair pulling is traction alopecia. Traction alopecia results from the chronic application of tensile force to scalp hair. The condition was described as early as 1907 in subjects from Greenland who had developed hair loss due to prolonged wearing of tight ponytails. Traditionally, the term “traction alopecia” has been related to specific hairstyles that cause increased tension on the scalp (e.g., ponytails, Afro-Caribbean hair styles with tight braiding (such as cornrows) or the tightly wound turbans of Sikh men). It has also been seen in female ballerinas. It is also seen in cultural traditions where the hair is voluntarily not cut in religious obeisance, which causes progressively increasing weight of the hair itself. Traction alopecia is mechanical in etiology, rather than androgenic. Management includes cessation of the chronic traction. However, this is unacceptable to people who favor the specific hairstyles and styling techniques that give rise to the condition.
Traction alopecia is one of the most common causes of hair loss in African American women. “Traction alopecia” includes hair loss or shedding due to increased traumatic force on hair follicles caused by hairstyle or mechanical hair procedures such as blow drying, flat ironing, hair curling and chronic brushing. Traction alopecia can also develop in patients constantly pulling their hair such as in trichotillomania. In traction alopecia, affected areas depend on the etiology of the disorder, but usually hair loss is localized on frontal and temporal scalp. According to population studies in African women, prevalence of traction alopecia varies from 17.1% in young women (6-21 years) to 31.7% in older women (18-86 years). Clinical features of traction alopecia include itching of the scalp, perifollicular erythema, scaling, folliculitis, and pustules, but it can also present as slow onset of hair loss without other symptoms. Primarily, traction alopecia is considered noncicatricial, yet excessive tension can lead to permanent alopecia, due to physical damage of hair follicles. Prolonged force on hair follicles may lead to inflammatory changes in immune cell infiltrate and fibrosis can result. Therefore, it is important to recognize the condition early, while it is still reversible.
In view of the popularity of hairstyles and hair techniques that pull at the hair and result in hair loss, there is a need for a product useful for treatment and prevention of hair loss associated with pulling on the hair.
PCT patent application WO2016/077744 entitled System and Method for Preventing Alopecia discusses treating traction alopecia by administering a composition containing an alpha-1 adrenergic receptor agonist to contract the arrector pili muscle. WO2016/077744 discusses that a suitable alpha-1 adrenergic receptor agonist is synephrine, among other compounds. p-synephrine (referred to as synephrine herein) is the primary protoalkaloid in Citrus aurantium (bitter orange) and in other Citrus species. Stohs, S. et al., Oxidative Medicine and Cellular Longevity, vol. 2011, Article ID 482973, pp. 1-9. The extract of bitter orange and synephrine have been marketed as dietary supplements purported to be a weight-loss aid and an appetite suppressant. They are also applied to the skin for pain, bruises, and bed sores. See Bitter Orange entry, National Center for Complementary and Integrative Health website, https://nccih.nih.gov/health/bitterorange (accessed Feb. 16, 2017). Bitter orange extract contains synephrine
U.S. Patent App. Pub. 20080107679A1 to Dilallo et al. describes a wrinkle reduction eye serum comprising an acetyl hexapeptide and REMODULINE® cosmetic product containing bitter orange flower extract sold by Silab. REMODULINE® comprises water, propylene glycol, and bitter orange flower extract, as reported in U.S. Patent App. Pub. 20080107679A1. The eye serum comprising bitter orange extract does not include PEG-6 caprylic/capric glycerides. U.S. Patent App. Pub. 20030235595 A1 to Chen et al. discloses pharmaceutical compositions including transesterification products of oils and alcohols that include PEG-6 caprylic/capric glycerides (sold under the brand name SOFTIGEN®676 (Huels) and GLYCEROX 767 (Croda).
It is an object of the present invention to provide compositions of synephrine or bitter orange extract that when applied topically to human skin or scalp reduce hair loss due to hair pulling activities, such as shampooing, brushing, combing, styling, applying hair weaves, etc. Such compositions may require high concentrations of synephrine and/or be formulated to allow for sufficient synephrine penetration of the skin to provide effective amounts of synephrine at the hair follicle to reduce hair loss due to pulling, and to prevent or reduce damage due to traction alopecia.